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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1949
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1949
Report date:
1949

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
acute and repeated dermal irritation test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butane-1,3-diol
EC Number:
203-529-7
EC Name:
Butane-1,3-diol
Cas Number:
107-88-0
Molecular formula:
C4H10O2
IUPAC Name:
(3R)-butane-1,3-diol; (3S)-butane-1,3-diol
Test material form:
liquid
Details on test material:
Name of test material (as cited in study report): 1,3-Butylenglykol, purity not stated

Method

Type of population:
general
Route of exposure:
dermal
Reason of exposure:
intentional
Details on exposure:
Volunteers were exposed to neat substance either at the intact upper arm and fore arm skin (single exposure: dose, occlusion and duration not stated, repeated exposure: 16 days, every other day, 5 g on 9 cm2, occluded for 24 h) or at the oral mucosa (dose and duration not stated).

Results and discussion

Results of examinations:
No signs of irritation were oberved at the skin or mouth mucosa in these test protocols.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test substance was not irritating to skin or mouth mucosa.
Executive summary:

Volunteers were exposed to neat test substance either at the intact upper arm and fore arm skin (single exposure: dose, occlusion and duration not stated, repeated exposure: 16 days, every other day, 5 g on 9 cm2, occluded for 24 h) or at the oral mucosa (dose and duration not stated). No signs of irritation were observed (Fischer et al., 1949; Loeser, 1949).